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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009397
Receipt No. R000011041
Scientific Title A prospective multicenter randomized controlled study of the efficacy of betamethasone valerate on umbilical granuloma.
Date of disclosure of the study information 2012/11/26
Last modified on 2018/12/27

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Basic information
Public title A prospective multicenter randomized controlled study of the efficacy of betamethasone valerate on umbilical granuloma.
Acronym A study of the efficacy of betamethasone valerate on umbilical granuloma.
Scientific Title A prospective multicenter randomized controlled study of the efficacy of betamethasone valerate on umbilical granuloma.
Scientific Title:Acronym A study of the efficacy of betamethasone valerate on umbilical granuloma.
Region
Japan

Condition
Condition umbilical granuloma
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of betamethasone valerate on umbilical granuloma with silver nitrate.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Cure rate and rate of adverse effects 1 week and 2 weeks after starting therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Silver nitrate; cauterization of the lesion with 20% silver nitrate.
Interventions/Control_2 Betamethasone valerate; application of betamethasone valerate ointment on the lesion twice a day every day for 1 or 2 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
1 weeks-old <=
Age-upper limit
6 weeks-old >
Gender Male and Female
Key inclusion criteria Neonates with umbilical granuloma from 1 to 5 weeks old.
Key exclusion criteria Patients who need surgical intervention
Patients with omphalitis
Target sample size 280

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Kojima
Organization Nagoya University Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address 65 Tsurumai-cho Showa-ku, Nagoya 466-8550, Japan
TEL +81-(0)52-744-2294
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chikako Ogawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address
TEL +81-(0)52-744-2294
Homepage URL
Email ogawa.chikako@j.mbox.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Department of Pediatrics
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0192688
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 10 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 04 Month 30 Day
Date trial data considered complete
2017 Year 05 Month 31 Day
Date analysis concluded
2017 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 11 Month 26 Day
Last modified on
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011041

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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